MAUDE Adverse Event Report: DRAEGER MEDICAL SYSTEMS, INC INFINITY DELTA; PHYSIOLOGIC MONITORING SYSTEM, SINGLE-PATIENT

Catalog Number MS18597

Device Problem No Audible Prompt/Feedback (2282)

Patient Problem Asystole (4442)

Event Date 02/07/2024

Event Type  Death  

Manufacturer Narrative

The investigation was started; results will be provided in a follow up-report.

Event Description

It was reported that the device did not sound the asystole alarm fast enough.It was further reported the patient died but the connection between the reported event and the patient death could not be clarified yet.

Manufacturer Narrative

The local dräger s&s organization has performed an on-site evaluation of the patient monitor and the central monitoring station.The patient monitor had a mechanical damage of the housing and was equipped with a non-dräger internal battery which was defective or did otherwise not allow operation without mains supply.Besides these non-conformities, monitoring was functional.The logs for the particular monitoring episode had been overwritten already since the device remained in further use.The logs of the central monitoring station had been erased as well.In general, the reported aspect of delayed alarming can neither be confirmed nor denied due to the fact that the information relevant for an assessment was not available.There is however no indication for the potential presence of a device malfunction.The non-conformities observed with the device should have prevented from putting it into use, but these have no relation to the reported event; monitoring was functional when the device was tested in follow-up of the event.Another aspect that substantiates the postulation that no device-related errors have likely occurred during the course of event is that the device was further used afterwards - an operator would probably not do this when significant concerns against the safety and performance of the device exist.A reliable conclusion in regard to the exact root cause for the reported event cannot be made.A number of contributing factors must be taken into consideration while - on the other hand - a differentiation is not possible due to lack of information.For example, if a sensor for a particular monitoring channel becomes detached from the patient (ecg electrodes, spo2 sensor), the device will post a technical alarm.It is in the nature of things that life-threatening conditions which occur in sensor-off condition cannot be detected anymore via this channel; the device will not post physiological alarms.It would also be plausible that a loss of network connection has interrupted the forwarding of alarms to the central station while the alarm posted by the bedside monitor was recognized with delay only.

Event Description

It was reported that the device did not sound the asystole alarm fast enough.It was further reported the patient died but the connection between the reported event and the patient death could not be clarified yet.

• Brand Name: INFINITY DELTA
• Type of Device: PHYSIOLOGIC MONITORING SYSTEM, SINGLE-PATIENT
• Manufacturer (Section D): DRAEGER MEDICAL SYSTEMS, INC; 3135 quarry road; telford PA
• Manufacturer (Section G): DRAEGER MEDICAL SYSTEMS, INC; 3135 quarry road; telford PA
• Manufacturer Contact: 3135 quarry road; telford, PA ; 2156602400
• MDR Report Key: 18812706
• MDR Text Key: 336600403
• Report Number: 1220063-2024-00026
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 04049098053457
• UDI-Public: (01)04049098053457(11)20111129(93)7489375
• Combination Product (y/n): N
• PMA/PMN Number: K152407
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MS18597
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/12/2024
• Initial Date FDA Received: 02/29/2024
• Supplement Dates Manufacturer Received: 03/22/2024
• Supplement Dates FDA Received: 03/27/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/19/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death